Intragastric balloons as an alternative to obesity treatment using drugs, behavior therapy, physical exercise and surgery are well known. For some time physicians have been placing intragastric balloons into the stomach reservoir to reduce the available area within the stomach and hence limit capacity for food. Once deployed in the stomach and expanded to its full size, the balloon helps to trigger a sensation of fullness and a decreased feeling of hunger. These prior art balloons are typically spherical, cylindrical or pear shaped, generally range in size from 200-700 ml or more, are made of an elastomer such as silicone, polyurethane, or latex, and are filled with air, water, or saline.
These prior art balloons are often inserted into the stomach in an deflated state via endoscope or swallowing and are then inflated with gas, liquid and sometimes foam using a tube passing through the mouth and oesophagus that actively inflates or expands the balloon. Other balloons include a tube exiting the nasal passage that allows the balloon to be periodically deflated and re-inflated to better simulate normal food intake. The need to inflate and/or deflate the balloon in the stomach can cause significant discomfort to the patient. Alternatively these prior art balloons can be inserted surgically and inflated during the surgery procedure. In all these arrangements the need to seal the intragastric balloon once it has been inflated or deflated arises.
With endoscopic oesophageal insertion and subsequent inflation and/or deflation or with surgical insertion there are inherent risks to the patient, some of these being perforation of the oesophagus and/or stomach, leakage or spillage of the material to be injected into the balloon and standard risks associated with anesthetic.
Some prior art intragastric balloons require gastric fluid to pass through the external wall of the balloon, causing material within it to expand due to added liquid. In these prior art balloons gastric fluid is able to continuously interact with the material within the balloon.
With the use of these prior art gastric balloons complications have also been observed, such as gastric ulcers, and small bowel obstructions caused by deflated balloons. In addition, there have been documented instances of the balloon blocking off or lodging in the opening to the duodenum, wherein the balloon may act like a ball valve to prevent the stomach contents from emptying.
The preceding discussion of the background art is intended to facilitate an understanding of the present invention only. The discussion is not an acknowledgement or admission that any of the material referred to is or was part of the common general knowledge as at the priority date of the application.